Legislation Lecture 6:Advertising of Sales of Medicinal Products

Question 1

Advertising:

Answer 1

Is acceptable provided it is in line with legislation and Good Practice.
High standards
Responsible
Not misleading
Not cause offence
SPC sets the boundaries for what can be claimed in an advert.
Different rules for POM, GSL and P.
Specials not allowed.
Each product must be licensed (MA, Herbal, etc)

Question 2

What’s not an advert:

Answer 2

Reference material – factual statements
Trade catalogues/price lists
Provided there is no product claim.
Information relating to human health or disease
Correspondence to answer a specific query about medicinal product.
Journal article
Labelling and package leaflet of a MP

Question 3

Regulations

Answer 3

Largely self-regulated
Overseen by MHRA – Executive agency
Protect the public health.
European Directive 2001/83/EC
The Human Medicines Regulations 2012 (part 14)
The Trade Descriptions Act 1968 - consumer
Consumer Protection from Unfair trading regulations 2008 (SI 2008) - consumer
The Business Protection from Misleading Marketing Regulations 2008 –business
Broadcasting Acts 1990 and 1996 – Broadcast advertising
Communications Act 2003 - Broadcast advertising
Bribery Act – Serious Fraud Office (SFO)!!

Question 4

Who is responsible for the advert?

Answer 4

Ultimately the Licence Holder.
Responsibility delegated to qualified signatories
Advertiser also has responsibility
Publisher also has responsibility
Offence for “Any person” to breach the regs.

Question 5

The Role of the MHRA

Answer 5

Key function is to protect public health by promoting the safe use of medicines
Methods used to regulate advertising
Checks advertising for compliance with the law prior to publication (vetting). Now done for all new medicines.
Monitors published advertising material
Handles complaints about advertising
Enforces regulations when material does not comply

Should potential breaches of the legislation be identified, a letter is sent to the advertiser outlining the Agency’s provisional view of the advertisement.

This will generally list the potential breach and any public health risk identified where appropriate, along with any action the advertiser is asked to take.

This may include a request to:
amend the advertisement,
withdraw the advertisement,
issue a corrective statement, and/or
submit future advertising for the product to the MHRA for review prior to issue (vetting).

Question 6

Advertising to the Public

Answer 6

Adverts for medication for self-medication (P +GSL)
Must not put patient or consumer safety at risk.
Government vaccination campaigns – exempt.
The Cancer Act 1939 – prohibits cancer remedies/treatments.
Psychotropic or Narcotic substances – prohibited.
Abortion – products prohibited.

Question 7

3 for 2 offers

Answer 7

MHRA discourages volume based promotion
Voluntary code.
MHRA best practice
No more than 2 packs sold in one transaction.
Discourages retailers from promoting offers

Question 8

Advertising to prescribers

Answer 8

Full advertisements must include:
Essential info compatible with SPC.
Sufficiently comprehensive information to enable reader to form an opinion.
1 or more of licensed indications
Dosage and method of use from SPC
Side-effects / C.I. / cautions / route
Product name/ active ingredients/ PL no./ legal status/ name and address of license holder

Question 9

Unacceptable

Answer 9

To imply that a product is “safe”
“placebo-like”
To mislead prescribers

Question 10

The Blue Guide

Answer 10

ADVERTISING AND
PROMOTION OF MEDICINES
IN THE UK